First H5N1 cattle vaccine trial authorized

As nearly 200 herds are being impacted by highly pathogenic avian influenza (HPAI), the U.S. Department of Agriculture (USDA) says there is work moving forward on an H5N1 vaccine.

During the 2024 Farm Progress Show, held Aug. 27-29 in Boone, Iowa, U.S. Secretary of Agriculture Tom Vilsack confirmed USDA will allow field safety trials of H5N1 vaccines in dairy cattle.

“The field trial is the next step in the development of a vaccine, which we’ll hopefully be able to develop in the near term with the information we get,” Vilsack states. “It will allow us to determine whether we can go to the next level and take the next steps necessary to ensure safe and effective use of the vaccine.”

USDA’s Center for Veterinary Biologics (CVB) in Ames, Iowa is overseeing the vaccine trial.

The secretary’s announcement comes after several agricultural industries, including dairy groups like the National Milk Producers Federation, sent a letter in support of the development of a safe and effective vaccine which can be used for dairy cows.

New H5N1 vaccine

Several companies are currently working on an H5N1 vaccine, but Vilsack says one company, Medgene, a South Dakota animal health vaccine manufacturer, has presented sufficient information allowing him to authorize the first field trial.

Medgene has been successful in producing prescription platform vaccines for swine, cattle, rabbits and deer, both in the U.S. and internationally. 

In a recent press release, Chief Operating Officer Tom Halbur says, “This is great news for us, for the CVB and, more importantly, the dairy industry. Our technology is founded on being able to respond to disease challenges faster. Our protocol satisfies the state’s requirements, and we’re looking forward to doing our part in supporting both the necessary regulatory policies and the dairy industry needs.”

According to a USDA spokesperson, “USDA has authorized the acceptance of licensure applications for an initial field study under specific conditions of nonviable, non-replicating vaccine against HPAI-H5 to be administered to dairy cattle to evaluate safety, as one part of several USDA vaccine licensure requirements.”

Multiple vaccine manufacturers have expressed interest in starting field safety trials, and USDA anticipates receiving formal field study proposals for review from interested manufacturers in upcoming weeks.

The agency is also considering granting conditional licenses for vaccines for lactating dairy cattle with either separate or combined field efficacy and field safety study data from those target animals.

While several dairy farmers view the vaccine as the answer to their H5N1 problem, there are many hurdles to overcome.  

Many questions about the logistics of vaccination and concerns about potential downsides exist, some of which may not be readily apparent. 

Medgene

Based in Brookings, S.D., Medgene develops vaccines addressing critical disease outbreaks, including HPAI. 

Medgene received the first USDA license to produce prescription platform vaccines for the cattle industry, which allows veterinarians to respond to diseases faster, more efficiently and safely. 

The manufacturer platform vaccine technology is also licensed for use in pigs, cattle, rabbits and deer and ensures all of the ingredients in its vaccines are animal-origin free.

According to Medgene, the company doesn’t target the whole virus, they stimulate an immune response against the virus, which is the basis for what they call their sub-unit vaccines. This is what they do with their prescription platform.

In an Aug. 28 Cattle Business Weekly article by Connie Sieh Groop, Medgene Chief Communications Officer John Mollison states, “What makes us unique is our ability, because of the way we’ve established our vaccines system, to rapidly swap out old proteins and put in new ones to adjust to new strains of influenza such as H5, new strains of other viruses or new viruses coming into our country, affecting animals that weren’t here yesterday. Instead of the traditional five-year, $5-million plus developmental timeline, we can do it in weeks.”

With the Medgene prescription platform, vaccines can be developed faster compared to other commercially available types, taking weeks instead of years.

The manufacturer operates under USDA regulations, with the basics of the vaccines already licensed and under USDA oversight.

Melissa Anderson is the editor of the Wyoming Livestock Roundup. Send comments on this article to roundup@wylr.net.